Could an online Brain-Gut therapy ease chronic stomach pain?
NCT ID NCT07636122
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether an internet-based cognitive behavioral therapy (iCBT) program is feasible and helpful for adults with functional gastrointestinal disorders (FGID), like irritable bowel syndrome (IBS). Thirty participants will complete a 10-week online program with therapist support, learning to manage symptoms through exposure exercises and behavior changes. The goal is to see if this approach is acceptable and reduces symptom severity and improves quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Internet-delivered cognitive behavioral therapy (iCBT)
- What this could lead to
- If it works, this could provide a convenient, accessible psychological treatment option for people with functional gut disorders, reducing symptoms and improving quality of life.
- What could go wrong
- This is a very small feasibility study with only 30 participants and no comparison group. It's too early to know if the treatment is effective, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18. 2. A primary diagnosis of functional disorders, gastrointestinal, specifically irritable bowel syndrome operationalized by ROME IV (DR58) 3. Normal recommended routine medical investigations: growth, blood samples including TSH, total IgA, IgA-tissue transglutaminase, complete blood count, erythrocyte sedimentation rate and C-reactive protein analysis, liver enzymes and fecal calprotectin. 4. Refractory gastrointestinal functional symptoms despite medical treatment (in accordance with guidelines) 5. Stable dosage of FGID-related medication such as laxatives, Imodium or pain-modulating psychopharmacological medication during the past month. 6. Living in Denmark. 7. Access to a computer or tablet with an internet connection. \- Exclusion Criteria: 1. \- Another disease that explains the symptoms. 2. Chronic inflammatory bowel disease (e.g., Crohns, colitis ulcerosa). 3. Lactose intolerance, celiac disease, and food allergies, in accordance with guidelines. 4. Severe psychiatric problems (e.g., suicidal ideation, depression). 5. Insufficient language or computer skills. 6. Addiction to alcohol, drugs or medicine. 7. Treatment with opioids or other addictive drugs such as benzodiazepines 8. Lactose-/gluten-intolerance where the diet has not been adjusted accordingly. 9. Severe cognitive or intellectual dysfunction or diagnosed autism spectrum disorder, which prevent the participant from interaction with the program 10. Ongoing psychological treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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